Country: Malasía
Tungumál: enska
Heimild: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Glucosamine Sulfate, Crystalline
MYLAN HEALTHCARE SDN. BHD.
Glucosamine Sulfate, Crystalline
90 Capsules; 60 Capsules; 6 Capsules
ROTTAPHARM LTD
VIARTRIL ® -S CAPSULE Glucosamine sulfate (500mg) 1 _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ WHAT IS IN THIS LEAFLET 1. What Viartril ® -S Capsule is used for 2. How Viartril ® -S Capsule works 3. Before you use Viartril ® -S Capsule 4. How to use Viartril ® -S Capsule 5. While you are using it 6. Side effects 7. Storage and Disposal of Viartril ® -S Capsule 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT VIARTRIL ® -S CAPSULE IS USED FOR Viartril ® -S Capsule is used as an adjuvant therapy for osteoarthritis (loss of cartilage in the joints). HOW VIARTRIL ® -S CAPSULE WORKS Viartril ® -S Capsule contains glucosamine sulfate as active ingredient. Glucosamine sulfate provides relief to joint disease by reducing joint swelling and pain. BEFORE YOU USE VIARTRIL ® -S CAPSULE - _When you must not use it _ _ _ Do not take Viartril ® -S Capsule if you have: • hypersensitivity to glucosamine or any other ingredients of this medicine (listed in Product Description) • allergies to shellfish as the active ingredient is obtained from seafood (shellfish) _ _ - _Before you start use it _ _ _ _Pregnancy and lactation _ Do not take Viartril ® -S Capsule if you are pregnant, trying to get pregnant or think you may be pregnant. Do not take Viartril ® -S Capsule if you are breast-feeding. Ask your doctor or pharmacist for advice before taking any medicine. Tell your doctor or pharmacist if you have: • asthma • a controlled sodium diet (the sodium content of this capsule is 151mg for 1500mg daily dose) • liver or kidney problems • diabetes or impaired glucose tolerance • another joint disease which may require alternative treatments - _Taking other medicines _ _ _ Tell your doctor or pharmacist if you are taking: • coumarinic anticoagulants (blood thinner) • tetracyclines (antibiotics) Pain relief or anti-inflammatory medicines can be taken together with Viartril ® -S Capsule. Tell your doctor if you are taking any other medicines, including a Lestu allt skjalið
Page 01 of 02 L1075F 05/09/2022 ▼ BLACK --- KEYLINE ---SAFE TEXT AREA 01 Leaflet Viartril-S 500mg Caps MY 148 X 210 (folded 148 X 26) mm Helvetica Neue (7 pt) N/A N/A D. Stancul PART NUMBER: DATE: PHARMACODE: BARCODE FORMAT & NUMBER: BRAILLE TEXT: ARTWORKER: INKS: TEMPLATE: PR JOB DESCRIPTION: KEYLINE REFERENCE: FONT USED: NAME: DATE: APPROVED & PROCEED AMEND & RE-SUBMIT SIGNATURE: OOF NUMBER: 3011 VIARTRIL ® –S 500 Glucosamine Sulfate Capsules 500 mg NAME OF THE MEDICINAL PRODUCT VIARTRIL ® -S COMPOSITION Each capsule contains: ACTIVE INGREDIENT Crystalline Glucosamine sulfate 628 mg Equivalent to: glucosamine sulfate 500 mg Sodium chloride 128 mg EXCIPIENTS Magnesium stearate, Talc. PHARMACEUTICAL FORM AND PRESENTATION Capsules. Package of 6, 60 and 90 capsules. MANUFACTURER ROTTAPHARM Ltd. Damastown Industrial Park, Mulhuddart DUBLIN 15, IRELAND THERAPEUTIC INDICATIONS Treatment of the symptoms of osteoarthritis, i.e. pain and function limitation. CONTRA-INDICATIONS Hypersensitivity to glucosamine or any of the excipients. As the active ingredient is obtained from seafood (shellfish), the product should not be given to patients who are allergic to shellfish. SPECIAL WARNINGS AND PRECAUTIONS FOR USE In asthmatic patients the product should be used with caution as these patients could be more susceptible to develop an allergic reactions to glucosamine with a possible exacerbation of their symptoms. The sodium content of oral formulations (151 mg for the 1500 mg daily dose) should be taken into consideration by patients on a controlled sodium diet. No special studies were performed in patients with renal or hepatic insufficiency. The toxicological and pharmacokinetic profile of the product does not indicate limitation for these patients. However, administration to patients with severe hepatic or renal insufficiency should be under medical supervision. Caution is advised in treatment of patients with impaired glucose tolerance. Closer monitoring of blood sugar levels may be necessary in diabetics at the begi Lestu allt skjalið